Adjuvant Therapy(3 vs. 6 Months) With the FOLFOX 4 or XELOX for Stage II or Stage III Colon Cancer
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01308086 |
|
Recruitment Status : Unknown
Verified August 2017 by Hellenic Oncology Research Group.
Recruitment status was: Active, not recruiting
First Posted : March 3, 2011
Last Update Posted : August 9, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| CRC | Drug: 5-Fluorouracil Drug: Leucovorin Drug: Oxaliplatin Drug: Capecitabine | Phase 3 |
Six months of adjuvant chemotherapy with 5-FU and oxaliplatin for patients with stage III colon cancer is the world-wide standard of care, based on the MOSAIC and C-07 trials. However, it leads to significant cost, toxicity, and inconvenience. In particular, the onset of oxaliplatin induced cumulative dose-dependent neuropathies is a significant issue. The ability to maintain efficacy with a reduced duration of therapy would have clear advantage to patients, to providers, and to the health care system.
Multiple large trials in the 1990s demonstrated that the previous standard of 12 months of therapy could be reduced to 6 months. A single small trial with 5-FU alone demonstrated similar outcomes for 3 versus 6 months of therapy. Thus, it is proposed to definitively evaluate the non-inferiority of 3 months of oxaliplatin-based adjuvant chemotherapy versus the current standard of 6 months. The primary endpoint will be disease-free survival (DFS).
It is essential to have sufficient power to eliminate the possibility of clinically meaningful inferiority of 3 months of therapy: a huge number of patients will be necessary. Previous efforts and experience have conclusively demonstrated that in colon cancer, a single, global trial is impractical. Consequently, an international, prospective pooled analysis will be performed, gathering data of independent trials run in different countries, to answer the single primary hypothesis that 3 months of adjuvant therapy with FOLFOX/XELOX is non-inferior to the current standard of 6 months. Among six planned countries, the Greek intergroup will conduct one of these trials.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2000 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter Trial Investigating the Duration of Adjuvant Therapy(3 vs. 6 Months) With the FOLFOX 4 or XELOX Regimen for Patients With High Risk Stage II or Stage III Colon Cancer |
| Study Start Date : | October 2010 |
| Estimated Primary Completion Date : | November 2017 |
| Estimated Study Completion Date : | December 2017 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: FOLFOX 4 - 6months or XELOX -6months |
Drug: 5-Fluorouracil
5-FU 400mg/m2 Bolus and then 22 hours 5-FU 600mg/m2 IV, days 1 & 2, q2w, for 12 cycles
Other Name: 5-FU Drug: Leucovorin Leucovorin 200mg/m2 IV in 2 hours, days 1 & 2, q2w, for 12 cycles Drug: Oxaliplatin Oxaliplatin 85mg/m2 in 2 hours IV, day 1, q2w, for 12 cycles
Other Name: LoHP Drug: Capecitabine Capecitabine 1000 mg/m2 X 2 ,days 1-14, q2w, for 8 cycles
Other Name: Xeloda Drug: Oxaliplatin Oxaliplatin 130 mg/m2 in 2 hours IV, day 1, q2w, for 8 cycles
Other Name: LoHP |
| Experimental: FOLFOX4 -3months or XELOX -3months |
Drug: 5-Fluorouracil
5-FU 400mg/m2 Bolus and then 22 hours 5-FU 600mg/m2 IV, days 1 & 2, q2w, for 6 cycles
Other Name: 5-FU Drug: Leucovorin Leucovorin 200mg/m2 IV in 2 hours, days 1 & 2, q2w, for 6 cycles Drug: Capecitabine Capecitabine 1000 mg/m2 X 2 ,days 1-14, q2w, for 4 cycles
Other Name: Xeloda Drug: Oxaliplatin Oxaliplatin 130 mg/m2 in 2 hours IV, day 1, q2w, for 4 cycles
Other Name: LoHP Drug: Oxaliplatin Oxaliplatin 85mg/m2 in 2 hours IV, day 1, q2w, for 6 cycles
Other Name: LoHP |
- Relapse Free Survival [ Time Frame: 3-years ]
- Overall Survival [ Time Frame: 3-years ]
- Safety Profil according to NCI-CTAE v 3.0 [ Time Frame: q2w ]Percentage (%) of treatments delays and interaptions in each arm Percentage (%) of dose received versus planned dose in each arm
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically- - confirmed adenocarcinoma of the colon or rectum stage III or stage with at least one of the follow characteristics T4 tumours, undifferentiated tumor grade >3, bowel obstruction or perforation, vascular or lymphatic or perineural invasion, <12 nodes examined, Stage IV.
- Signed written informed consent
- Randomization between 2 -8 weeks after curative surgery
- Age >18 years
- ECOG performance Status 0-1
- Pretreatment CEA within UNL
- Post-menopausal women or women willing to accept the use of an effective contraception. Pre-menopausal women should have a negative pregnancy test within 72 hours prior to randomization
- Men should also accept to use an effective contraception
- R0 resections
Exclusion Criteria:
- Evidence of metastatic disease (including presence of tumor cells in ascites or peritoneal carcinomatosis resected "en bloc")
- Evidence of other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
- No pregnant or lactating women
- Presence of clinically relevant cardiovascular disease
- Presenc of medical history or current evidence of CNS disease
- Presence of peripheral neuropathy ≤ grade 1 (CTCAE v. 3.0)
- History of clinically relevant psychiatric disability, precluding informed consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308086
| Greece | |
| University Hospital of Crete, Dep of Medical Oncology | |
| Heraklion, Greece | |
| Principal Investigator: | John Souglakos, MD | University Hospital of Crete, Dep of Medical Oncology | |
| Study Chair: | Vassilis Georgoulias, MD | University Hospital of Crete, Dep of Medical Oncology |
| Responsible Party: | Hellenic Oncology Research Group |
| ClinicalTrials.gov Identifier: | NCT01308086 |
| Other Study ID Numbers: |
CT/09.12 |
| First Posted: | March 3, 2011 Key Record Dates |
| Last Update Posted: | August 9, 2017 |
| Last Verified: | August 2017 |
|
Cancer colorectal cancer adjuvant chemotherapy |
capecitabine oxaliplatin 5 fluorouracil |
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Leucovorin Capecitabine Fluorouracil |
Oxaliplatin Levoleucovorin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antidotes Protective Agents Vitamin B Complex Vitamins Micronutrients |